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RecruitingNCT07442357PAPPIUpdated Oct 5, 2026

The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial

An interventional study of Beta-lactam antibiotic with spectrum for Enterococcus faecalis and Cephalosporin in Aortic Valve Stenosis, sponsored by Copenhagen University Hospital, Rigshospitalet. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Oct 5, 2026Now RecruitingFirst site in Sweden+5 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,986
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study is a prospective, crossover, cluster randomized trial in patients undergoing transcatheter aortic valve implantation (TAVI). The study tests whether cephalosporin plus beta-lactam antibiotic with spectrum for Enterococcus faecalis as per procedural prophylaxis is superior to cephalosporin alone in reducing the composite outcome of bacteremia or death at 6 months post-TAVI.

Read the detailed description

The PAPPI trial is designed as a prospective, crossover, unblinded, cluster randomized trial. The study includes all TAVI centers in Denmark. Each center will be included for either single dose cephalosporin (1st, 2nd or 3rd generation) plus a beta-lactam antibiotic with spectrum for Enterococcus faecalis (e.g. ampicillin 2g) or single dose of a cephalosporin (1st, 2nd or 3rd generation) as antibiotic prophylaxis in relation to TAVI. The antibiotic(s) will be given as a single dose intravenously per-procedural. Patients will be followed from date of TAVI procedure until 6 months post procedure.

The primary outcome of the PAPPI trial will be a composite of the following components within 6 months post TAVI:

  • Bacteremia (excluding all enterobacterales)
  • Death

Secondary outcomes will be each separate component of the primary outcome and will be ana-lyzed separately as time-to-first event analysis. Additional secondary outcomes will be;

  • Bacteremia (excluding all enterobacterales)
  • Acute kidney failure
  • Death
  • Length of hospital stay
  • Days-out-of-hospital from TAVI to 6 months
02

Conditions studied

  • Aortic Valve Stenosis

Keywords

  • Aortic Valve Stenosis
  • Aortic Valve Replacement
  • Transcatheter Aortic Valve Replacement
  • Aortic Valve
  • Cephalosporin
  • Ampicllin
  • Bacteremia
  • Per Procedure Prophylaxis
03

In context

Aortic Valve Stenosis

1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

This study's planned enrollment of 1,986 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 42 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients > 18 years of age undergoing TAVI at sites in Denmark

Exclusion criteria

Exclusion Criteria:

  • Patients who do not want to participate and have chosen to "opt-out" of the trial
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
1,986 participants (estimated)

Study arms

  • Active comparator
    Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis

    Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis

    Drug: Beta-lactam antibiotic with spectrum for Enterococcus faecalis · Drug: Cephalosporin

  • Active comparator
    Cephalosporin (1st, 2nd, 3rd generation)

    Cephalosporin (1st, 2nd, 3rd generation)

    Drug: Cephalosporin

Interventions

  • DrugBeta-lactam antibiotic with spectrum for Enterococcus faecalis

    Beta-lactam antibiotic with spectrum for Enterococcus faecalis (e.g. ampicillin 2g) add-on in combination with cephalosporin as per-procedural prophylaxis in TAVI

  • DrugCephalosporin

    Cephalosporin treatment

06

What researchers measure

Primary outcomes

  1. Number of patients with a composite outcome of bacteremia or death by 6 months.

    Bacteremia is defined as having positive blood cultures (excluding all enterobacterales) registered in the Danish Microbiological Database at 6 months post-TAVI. Death is defined as being registered as deceased in the Danish Civil Registration System at 6 months post-TAVI.

    Time frame: 6 months post-TAVI

Secondary outcomes

  1. Number of patients who died by 6 months

    Death is defined as being registered as deceased in the Danish Civil Registration System 6 months post-TAVI.

    Time frame: 6 months post-TAVI

  2. Bacteremia assessed by collection of blood cultures.

    Bacteremia is defined as having positive blood cultures (excluding all enterobacterales) registered in the Danish Microbiological Database at 6 months post-TAVI.

    Time frame: 6 months post-TAVI

  3. Number of patients with acute kidney failure assessed by plasma creatinine levels.

    Acute kidney failure is defined as ≥50% increase in the plasma creatinine within 6 months post-TAVI and information on plasma creatinine levels is obtained from the national blood sample data.

    Time frame: 6 months post-TAVI

  4. Length of hospital stay

    Length of hospital stay in relation to the TAVI-procedure

    Time frame: From the day of TAVI-procedure until the day of discharge after the TAVI-procedure e.g. days from TAVI-procedure until discharge assessed up to 6 months post-TAVI due to end of follow-up.

  5. Days-out-of-hospital from TAVI to 6 months

    Days-out-of-hospital from TAVI to 6 months

    Time frame: 6 months post-TAVI

07

Study locations

4 of 5 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2026 (actual). Primary completion is estimated for Mar 2030, 41 months after the start.

Of 177 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's planned 41 months is below that.

Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.

Start moved once since we started tracking on Sep 25, 2026: Jun 2026 → Oct 2026, on Sep 29, 2026.

Primary completion moved twice since we started tracking on Sep 25, 2026: Jun 2029 → Mar 2030, last on Oct 5, 2026.

Completion moved twice since we started tracking on Sep 25, 2026: Jun 2029 → Mar 2030, last on Oct 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Feb 19, 2026
First posted
Mar 2, 2026
StartActual
Oct 1, 2026was Jun 2026
Primary completionEst.
Mar 31, 2030was Jun 2029
CompletionEst.
Mar 31, 2030was Jun 2029
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 29, 2026
Sites
4 sites added — first site in Sweden. Copenhagen University Hospital, Rigshospitalet is now Recruiting
Show 4 added (3 Denmark, 1 Sweden)
  • Aalborg University Hospital · Aalborg, Denmark
  • Aarhus University Hospital · Aarhus, Denmark
  • Odense University Hospital · Odense, Denmark
  • Skåne University Hospital Lund · Lund, Sweden
Sep 29, 2026
Start date
Jun 1, 2026→Oct 1, 2026
Sep 29, 2026
Primary completion
Jun 1, 2029→Mar 31, 2030
moved 2 times, Sep 29, 2026 – Oct 5, 2026
Study completion
Jun 1, 2029→Mar 31, 2030
moved 2 times, Sep 29, 2026 – Oct 5, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Copenhagen University Hospital, Rigshospitalet · Copenhagen, DenmarkContact added e•••@regionh.dk · •••6340
Sep 29, 2026
Show all 2 updates
  1. Oct 5, 2026
    Primary completion Mar 31, 2029→Mar 31, 2030
    Study completion Mar 31, 2029→Mar 31, 2030
    + 1 other change: verification date
  2. Sep 29, 2026
    Not yet recruiting→Recruiting
    4 sites added — first site in Sweden. Copenhagen University Hospital, Rigshospitalet is now Recruiting
    Show 4 added (3 Denmark, 1 Sweden)
    • Aalborg University Hospital · Aalborg, Denmark
    • Aarhus University Hospital · Aarhus, Denmark
    • Odense University Hospital · Odense, Denmark
    • Skåne University Hospital Lund · Lund, Sweden
    Start date Jun 1, 2026→Oct 1, 2026
    Primary completion Jun 1, 2029→Mar 31, 2029
    Study completion Jun 1, 2029→Mar 31, 2029
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Copenhagen University Hospital, Rigshospitalet · Copenhagen, DenmarkContact added e•••@regionh.dk · •••6340
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07442357
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Responsible party
Emil Loldrup Fosbol (Professor, MD, PhD, Copenhagen University Hospital, Rigshospitalet) — Principal investigator
First posted
Mar 2, 2026
Start date
Oct 1, 2026
Primary completion
Mar 31, 2030 (estimated)
Completion
Mar 31, 2030 (estimated)
Last update
Oct 5, 2026

Study contacts

Emil L Fosbøl, MD, PhD
Contact
emil.fosboel@regionh.dk
+ 45 35 45 63 40

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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